Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Completed · Phase 2

Conditions studied: HIV Infections, Lipodystrophy

In brief

The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood. PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However, some people who take PIs have higher than normal levels of fats and/or sugars in the blood. Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects. This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low.

Key facts

Study ID

NCT00021463

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

342

Last updated by the study team

2011-02-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV infected.
• Are on their first combination of stable anti-HIV drugs (have not changed drugs for at least 6 months, except for reasons other than failing treatment or short interruptions of less than 7 days).
• Have 2 measurements of viral load (amount of HIV in the blood) during the 6 months before entering the study that are below 400 copies/ml by RT-PCR test or below 500 copies/ml by branched DNA test, measured at least 8 weeks apart.
• Have a viral load below 50 copies/ml within 30 days prior to entry.
• Have a CD4 cell count of 200 copies/ml or higher within 60 days of study entry.
• Are receiving medications and/or medications at certain doses that might interfere with the study.
• Are at least 13 years old and have signed consent of parent or guardian if under 18 years of age.
• Have a negative pregnancy test within 14 days of study entry, if a woman able to have children.
• Agree to use a barrier method of birth control, men and women, while receiving study drugs and for 3 months afterwards.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Are receiving high doses of testosterone. Low doses are allowed if received for 60 or more days before entering the study with no plans to change the dose during the first 24 weeks of the study.
• Have had treatment with any nonnucleoside reverse transcriptase inhibitor (NNRTI).
• Have had treatment with ABC.
• Are allergic to study drugs or any ingredient in them.
• Are pregnant or breast-feeding.
• Have used any HIV vaccine or drugs affecting the immune system within 30 days prior to entering the study.
• Have had systemic treatment for cancer within 30 days of entering the study.
• Have had systemic treatment with certain other drugs that may interfere with the study within 14 days of entering the study.
• Have a serious illness that required systemic treatment or a hospital stay unless treatment was completed at least 14 days prior to entering the study, or are on stable treatment, in the doctor's opinion, for at least 14 days prior to entering the study.
• Abuse drugs or alcohol.
• Have or suspect they have acute hepatitis within 30 days of entering the study.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Emory Univ — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Brigham and Women's Hosp — Boston, Massachusetts, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.